General description
This one-day course provides an in-depth knowledge of good design practices for aseptic and sterilizing filtration processes. Based on fundamental design principles, it covers good engineering practices for sterile liquid and gas filtration. Standard operating procedures (SOPs) and validation approaches are reviewed for fixed and autoclaved filtration equipment. Attention is given to current topics like pre-use post-sterilization integrity testing (PUPSIT), redundant filtration, single-use gamma-irradiated assemblies, and hybrid (i.e. a combination of stainless steel and disposable components) solutions for liquid transfer.